AKI
Conditions
Keywords
AKI, open vascular surgery, endovascular surgery, aortic arch reconstruction, Acute Kidney Injury
Brief summary
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of NAD+ supplementation with Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.
Interventions
DRUGNicotinamide Riboside + Pterostilbene
It will be administered a total of 1000 mg/day of NR and 200 mg/day of Ptero in a regimen of 2 capsules of Basis™ (each capsule 250 mg of NR and 50 mg of Ptero) 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
DRUGPlacebo
The correspondent placebo will be administered in a regimen of 2 capsules 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
Sponsors
Elysium Health
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of NAD+ supplementation with Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A patient may be included in the study if the following conditions are present: 1. Male or female; 2. Age \> 18 years old; 3. Patients who match the criteria for indication of elective open aortic arch replacement or repair: 1. Total arch; 2. Non-total arch; 4. Patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions: a. Patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms Crawford extent I to IV ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. For endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV of chronic kidney disease (CKD); ii. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and solitary or single functioning kidney and known stage III or IV CKD; 5. Patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug.
Exclusion criteria
* Patients must be excluded from the study if any of the following conditions are true: 5.2.1 General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AKI | 6 months | The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel ischemia | 6 months | The secondary endpoint will be change in the incidence of bowel ischemia |
| Spinal cord injury | 6 months | The secondary endpoint will be change in the incidence of spinal cord injury |
| Myocardial infarction | 6 months | The secondary endpoint will be change in the incidence of myocardial infarction |
| Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7) | 6 months | TIMP2, KIM-1, IGFBP7 levels in urine |
| Quinolinate and Tryptophan | 6 months | Quinolinate and Tryptophan levels in urine |
| Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR) | 6 months | NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs) |
Countries
United States
Outcome results
None listed